DECLARATION OF CONFORMITY
The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the following swimming goggles comply with the requirements of EU Regulation 2016/425 according to the standard BS 5883: 1996.
The above EU declaration of conformity is issued under the sole responsibility of the manufacturer.
The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the diving masks below are in conformity with the requirements of the EU Regulation 2016/425 according to the standard EN16805 :2015.
The above EU declaration of conformity is issued under the sole responsibility of the manufacturer.
The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the following ski masks comply with the requirements of EU Regulation 2016/425 according to the standard EN 174: 2001.
The above EU declaration of conformity is issued under the sole responsibility of the manufacturer.
The company : OPAL DEMETZ SAS
EUDAMED Single registration Number (SRN) : FR-MF-000003768
Address : 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09– France
International nomenclature : GMDN 32816
This declaration of conformity is issued under the sole responsibility of OPAL DEMETZ.
Opal DEMETZ declare that the product groups described in this declaration, can be defined as Class I Médical Devices (Rule 1, Chapter III, of de Annex VIII of EU regulation 2017/745) and are intended for use in connection with ophthalmic lenses for correcting vision problems.
Product Groups Basic UDI DI EMDN Code
Plastic Frame Full rim 360830F0FR0PLAKK Q02100202
Metal Frame Full rim 360830F0FR0METKM Q02100201
Metal Frame Half rim 360830F0HR0METLF Q02100201
Metal Frame Other type 360830F0OT0METPY Q02100201
Theses products complies with the applicable requirements of the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, and complies with European Standard EN ISO 12870 : 2016.
The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the following sun protection glasses comply with the requirements of the EU Regulation 2016/425 according to the standard EN ISO 12312-1: 2022.
The above EU declaration of conformity is issued under the sole responsibility of the manufacturer.
The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the eye protection glasses below comply with the requirements of the EU Regulation 2016/425 according to the standard EN 166:2002 or ASTM F803.
The above EU declaration of conformity is issued under the sole responsibility of the manufacturer.
Lyon, 25th November 2021
OPAL DEMETZ
François FORT
Chief Operating Officer
